04
Aug
2011

Cl ll DICOM Query/Retrieve

0

Company:Medtronic Navigation, Inc
Date of Enforcement Report 8/3/11
Class ll:

PRODUCT
DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthStation systems. Product Usage: DICOM Query/Retrieve software enables the user to query a hospital Picture Archiving and Communication System (PACS) for patient DICOM scans. The user can then transfer the identified scan to a Medtronic StealthStation system. Recall # Z-2781-2011

REASON
Software allows incorrect patient or patient history to be displayed.

RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc., Louisville, CO, by letter dated June 2, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
81 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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